GMP Implementation of Online Water Bioburden Analyzers

About the Author

Clean Utility Specialist

Novo Nordisk

Jesper Hjorth was educated as a marine engineer and has worked since 2006 at Novo Nordisk. As Utility Specialist he is mainly responsible for supply...

Peter Annel

Principal Scientist

Novo Nordisk A/S

Peter Annel is a Principal Scientist at Novo Nordisk A/S. He has a DVM from the University of Copenhagen, Faculty of Life Sciences (formerly the...

Peter Noverini

Microbiologist

Baxter Healthcare Corporation

Peter Noverini is a Microbiologist at Baxter Healthcare Corporation, specializing in the evaluation of alternative and rapid microbiological methods and their application to environmental monitoring...

Scott Hooper, PhD

Director and Head of the Microbiology Lab

Merck

Scott Hooper has over 30 years of experience in academics and industry in the US and Europe. He holds a PhD in microbiology and is...

Technical

Selection Criteria for Pharmaceutical Containment Equipment

1 March 2024

Pharmaceutical manufacturing facilities produce a variety of products, including highly potent products that require safety measures to prevent adverse health effects on patients and operators. To ensure safety, these facilities use containment equipment to minimize the risk of contamination. This article presents criteria for selecting containment equipment, considering both...

Technical

A Sustainable Approach to Steam Quality Management

1 March 2024

The world is beginning to grasp the huge challenge of achieving net-zero carbon emissions, or carbon neutrality, by 2050. Many countries have committed to achieving this ambitious goal. As a major global industry, the pharmaceutical sector has a significant role to play. For thermal energy–intensive industries, such as pharmaceutical manufacturing, the long-term future options to maintain...

Technical

Concluding Compliance Challenges with Validation 4.0

13 March 2024

As the pharma industry moves to an ambitious Validation 4.0 paradigm, computerized systems play a pivotal role in enabling the rapid transition. Innovation and agility in computerized system validation (CSV) received a strong push in the second half of 2022 with the publication of the FDA draft guidance on “Computer Software Assurance for Production and Quality System Software”

About the Author

Facilities of the Future: Meeting the Demands of Breakthrough Therapeutics

Emerging Leader Hacker to GAMPer in 10 Weeks

New Initiative Seeks to Back up ICHs Harmonization Mission

Data Science-Assisted Biopharmaceutical Tech Transfer and Process Characterization

Entering a New Era of Innovation and Collaboration With the Focus on the Workforce of the Future

Q&A with ISPE Foundation Professional Development Grant Recipient Silas Tamufor

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